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College of Medicine University Medical Center |
Arizona Health Sciences Center University Physicians Healthcare |
Please follow this link for information on this study.
[Study Sponsor: Visualase, Inc.; Principal Investigator: David Labiner, MD]
The University of Arizona - Department of Neurology is conducting this research study to find out whether a new procedure, called Visualase Thermal Therapy System, is a safe and minimally invasive treatment option for patients with epileptic lesions. Thermal Therapy is the use of laser light to destroy the affected tissue through heat.
The Visualase Thermal Therapy System uses a technique called laser interstitial thermal therapy or LITT to heat and "kill" soft tissues inside the body. A thin fiber optic applicator is inserted into the center of the target tissue and delivery of laser energy causes the tissue to heat up, literally "cooking" it from the inside out. The Visualase procedure is done while the patient is inside of a magnetic resonance imaging (MRI) machine. While the laser energy is being delivered, MRI pictures are taken and converted into maps of the heat that is being delivered. In this way, the doctor can monitor the progress of the LITT procedure and make sure that only the target tissue is destroyed.
This study is currently being done at Texas Children's Hospital in Houston, TX. The following Internet links are for 2 separate news stories regarding this research study. Both stories focus on one patient's case, a 9 year old boy, who suffered from two types of seizures that disrupted everything in his life. Both news stories explain the procedure and the outcome that the patient experienced after undergoing this research procedure. The news story from CBS News offers a very informative illustration of the actual procedure.
The two Internet links are as follows:
[Study Sponsor: Sunovian; Principal Investigator: David Labiner, MD]
The University of Arizona - Department of Neurology will be testing the safety and effectiveness of an investigational medication (Eslicarbazepine Acetate) when used with other antiepileptic drugs, in reducing the number of seizures experienced by people with partial onset seizures.
To qualify for this study, you must:
Patients must discontinue their current antiepileptic medications to participate; however, at no time during the study will they be required to go without any medication. With the supervision of the study doctor, after participants are already taking the study medication, their current treatments will be slowly tapered down.
Qualified participants will receive study-related medical evaluations and the study medication at no cost. Reimbursement for time and travel may also be provided.
If you decide to enroll in this study, your total participation will last up to 29 weeks, with at least ten visits to the study clinic. Once you reach the targeted dose of the investigational medication, you will gradually discontinue your current treatment. During the clinic visits, you will undergo a series of medical tests and evaluations to monitor your safety and progress. These assessments will include, but not be limited to:
If you are a woman of childbearing potential, you will also be given a pregnancy test. If you are pregnant, you will not be allowed to participate in this study.
Additionally, you will be provided with a seizure diary and will be required to document any seizures you have during participation. You will also be given a medical events calendar and will be asked to record any changes in medications you are taking or any illnesses that occur. Between study visits, you will be contacted by phone regularly so that study staff can continue to check on you and discuss any questions you may have.
[Study Sponsor: Sunovian; Principal Investigator: David Labiner, MD]
You must have participated in the "Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects with Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs" study in order to be eligible for participation in this study.
[Study Sponsor: Eisai; Principal Investigator: David Labiner, MD]
If you are interested in seeing if someone you know is eligible to participate in any of these studies or if you just want more information, please contact:
Susan Merski, BSN, RN
Research Nurse, Sr.
(520) 626-4296
University of Arizona, Health Science Center, Department of Neurology
1501 N. Campbell Avenue, Room 7329
Tucson, AZ 85724-5023
Fax: 520-626-4903